Pravastatin Sodium Tablets recall
FDA recall D-0612-2024 · initiated Jun 28, 2024
Glenmark Pharmaceuticals Inc., USA recalled Pravastatin Sodium Tablets in Jun 2024 — an FDA Class II recall (D-0612-2024) because Failed Dissolution Specifications: results below specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: results below specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: a) 145,800 bottles; b) 1,368 bottles
Details
- Product
- Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jun 28, 2024
- FDA report date
- Jul 24, 2024
Frequently asked
- Was Pravastatin Sodium Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Pravastatin Sodium Tablets in Jun 2024 — an FDA Class II recall (D-0612-2024) because Failed Dissolution Specifications: results below specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Pravastatin Sodium Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0612-2024 was: Failed Dissolution Specifications: results below specifications
- Is a recalled Pravastatin Sodium Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Pravastatin Sodium Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: a) 17211249, 17211264, 17211266,17211286, Exp 6/30/24; 17211525, 17211535, 17211549, Exp 7/31/24; 17211787, 17211801, 8/31/24; 17212041, 9/30/24; 17212088, 17212106, Exp 10/31/24; 17212346, 17212345, 11/30/24; 17220053, 17220054, 17220055 12/31/24; 17220309, 17220310, Exp 1/31/25; b) 17211290, 6/30/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0612-2024.